Xetorib

Patient Information Leaflet: Information for the User

XETORIB 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Equivalent medicine
Etoricoxib
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What XETORIB is and what it is used for
2. What you need to know before taking XETORIB
3. How to take XETORIB
4. Possible side effects
5. How to store XETORIB
6. Contents of the pack and other information

1. What XETORIB is and what it is used for

XETORIB belongs to a group of medicines called selective COX-2 inhibitors.
These belong to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
XETORIB helps reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and older with osteoarthritis,
rheumatoid arthritis, ankylosing spondylitis, and gout.
XETORIB is also used for the short-term treatment of moderate pain
following dental surgery in people aged 16 years and older.
What is osteoarthritis?
Osteoarthritis is a joint disease. It is caused by the progressive
degeneration of the cartilage covering the ends of bones. This leads to
swelling (inflammation), pain, tenderness, stiffness, and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term inflammatory joint disease.
It causes pain, stiffness, swelling, and progressive loss of movement in affected joints. It may also cause inflammation in other parts of the body.
What is gout?
Gout is a condition characterized by sudden and recurrent attacks of very painful inflammation and redness in the joints. It is caused by the deposition of mineral crystals in the joints.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

2. What you need to know before taking XETORIB

Do not take XETORIB:

• if you are allergic (hypersensitive) to etoricoxib or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see section 4, Possible side effects)
• if you currently have a stomach ulcer, or active bleeding in your stomach or intestines
• if you have severe liver disease
• if you have severe kidney disease
• if you are pregnant or could be pregnant, or if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”)
• if you are under 16 years of age
• if you have an inflammatory bowel disease such as Crohn’s disease, ulcerative colitis, or colitis
• if you have high blood pressure that is not controlled by treatment (consult your doctor or pharmacist if you are unsure whether your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems, including heart failure (moderate or severe), or angina (chest pain)
• if you have had a heart attack, coronary bypass surgery, or peripheral arterial disease (reduced circulation in legs and feet due to narrowed or blocked arteries)
• if you have ever had a stroke (including mini-stroke, transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and for this reason should not be used in people who have already had heart problems or stroke.

If you think any of these conditions apply to you, do not take these tablets before consulting your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking XETORIB if:

• You have a history of stomach bleeding or ulcers.
• You are dehydrated, for example due to a prolonged episode of vomiting or diarrhoea.
• You have swelling due to fluid retention.
• You have a history of heart failure or any other form of heart disease.
• You have a history of high blood pressure. In some people, XETORIB, especially at high doses, may increase blood pressure, and your doctor will periodically check your blood pressure.
• You have a history of liver or kidney disease.
• You are being treated for an infection. XETORIB may mask or hide fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker. These are conditions that may increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years of age.

If you have any doubts about any of the conditions listed above, talk to your doctor
before taking XETORIB to check whether this medicine is suitable for you.

XETORIB has the same efficacy in younger and older patients. If you are over 65 years of age, your doctor will monitor you appropriately. No dose adjustment is necessary for patients over 65 years of age.

Children and adolescents

Do not give this medicine to children or adolescents under 16 years of age.

Other medicines and XETORIB

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, if you are taking any of the following medicines, your doctor may need to carry out checks to ensure these medicines are working properly once you have started taking XETORIB:

• medicines that thin the blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and often used in the treatment of rheumatoid arthritis)
• ciclosporin or tacrolimus (medicines used to suppress the immune system)
• lithium (a medicine used to treat certain types of depression)
• medicines used to help control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor antagonists, such as enalapril and ramipril, and losartan and valsartan
• diuretics
• digoxin (a medicine for the treatment of heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• oral salbutamol tablets or oral solution (a medicine for the treatment of asthma)
• oral contraceptives (combination therapy may increase the risk of side effects)
• hormone replacement therapy (combination therapy may increase the risk of side effects)
• acetylsalicylic acid – the risk of stomach ulcers is higher if you take XETORIB with acetylsalicylic acid.
• XETORIB may be taken with a low dose of acetylsalicylic acid. If you are taking low-dose aspirin for the prevention of heart attacks or strokes, do not stop taking aspirin without consulting your doctor.
• You should not take a high dose of acetylsalicylic acid or other anti-inflammatory medicines while taking XETORIB.

XETORIB with food and drink

The onset of XETORIB’s effect may be faster when taken without food.

Pregnancy, breastfeeding and fertility

Pregnancy

XETORIB tablets must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. If you are unsure or need further information, consult your doctor.

Breastfeeding

It is not known whether XETORIB is excreted in human milk. If you are breastfeeding or planning to breastfeed, contact your doctor before taking XETORIB. You must not breastfeed while taking XETORIB.

Fertility

XETORIB is not recommended for women intending to become pregnant.

Driving and using machines

Some patients taking XETORIB have reported dizziness and drowsiness.

Do not drive if you experience dizziness or drowsiness.

Do not operate tools or machinery if you experience dizziness or drowsiness.

XETORIB contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

XETORIB contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take XETORIB

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Do not take more than the recommended dose for the treatment of your condition. Your doctor
will periodically evaluate your treatment. It is important that you use the lowest effective dose
capable of controlling your pain and that you do not take XETORIB longer than necessary.
This is because the risk of heart attack and stroke may increase with prolonged treatment,
especially at high doses.
Different dosage strengths are available for this medicine, and depending on your condition,
your doctor will prescribe the tablet strength appropriate for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once daily, which may be increased, if necessary, up to
a maximum dose of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 90 mg once daily.
Acute pain conditions
Etoricoxib should be used only for the duration of the acute pain.
Gout
The recommended dose is 120 mg once daily, which should be used only for the duration of
acute pain, limited to a maximum of 8 days of treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3
days of treatment.
Patients with liver problems
If you have mild liver disease, you should not take more than 60 mg per day.
If you have moderate liver disease, you should not take more than 30 mg per day.
Use in children and adolescents
XETORIB tablets must not be taken by children or adolescents under
16 years of age.
Elderly
Dose adjustment is not required in elderly patients. As with other
medicines, caution should be exercised in elderly patients.
Method of administration
XETORIB is for oral use. Take the tablets once daily. XETORIB may
be taken with or without food.
If you take more XETORIB than you should
Never take more tablets than those recommended by your doctor. If you take
too many XETORIB tablets, contact a doctor immediately.
If you forget to take XETORIB
It is important to follow the XETORIB dose prescribed by your doctor. If you
forget a dose, simply resume your usual dosing schedule the next day. Do not take a double
dose to make up for the missed tablet.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following symptoms, you must stop treatment with XETORIB
and contact your doctor immediately (see section 2 “What you should know before taking
XETORIB”):

• shortness of breath, chest pain, or swelling of the ankles that develop or begin to worsen
• yellowing of the skin and eyes (jaundice) – these are symptoms of liver problems
• severe or persistent stomach pain or black stools
• an allergic reaction which may include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may make breathing difficult

The frequency of the possible side effects listed below is defined using the following convention:
Very common (may affect more than 1 in 10 people)
Common (may affect 1 to 10 people in 100)
Uncommon (may affect 1 to 10 people in 1,000)
Rare (may affect 1 to 10 people in 10,000)
Very rare (may affect less than 1 in 10,000)

The following side effects may occur during treatment with XETORIB:

Very common

• stomach pain

Common

• dry socket (inflammation and pain after a tooth extraction)
• swelling of the legs and/or feet due to fluid retention (oedema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
• increased blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, flatulence (excess gas), gastritis (inflammation of the inner stomach lining), heartburn, diarrhoea, difficulty in digestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• changes in certain blood tests related to liver function
• appearance of bruises
• weakness and fatigue, flu-like illness

Uncommon

• gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine), upper respiratory tract infection, urinary tract infection
• changes in laboratory test values (decreased number of red blood cells in the blood, decreased number of white blood cells in the blood, decreased platelets)
• hypersensitivity (an allergic reaction including hives, which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, reduced mental sharpness, visual, sensory or auditory perceptions not caused by real stimuli (hallucinations)
• altered taste, difficulty sleeping, tingling or numbness, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (persistent sensation of dizziness)
• abnormal heart rhythm (atrial fibrillation), increased heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
• hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, difficulty breathing, nosebleeds
• stomach or intestinal bloating, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner stomach lining which may become severe and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• swelling of the face, skin rash or skin itching, skin redness
• muscle cramps/spasms, muscle pain/stiffness
• high levels of potassium in the blood, changes in certain blood or urine tests related to kidney function, severe kidney problems
• chest pain

Rare

• angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and swallowing, which may be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a severe allergic reaction requiring immediate medical attention)
• confusion, restlessness
• liver problems (hepatitis)
• low levels of sodium in the blood
• liver failure, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store XETORIB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What XETORIB contains
The active substance is etoricoxib. Each film-coated tablet contains 60 mg, 90 mg, or 120 mg of etoricoxib.
60 mg, 120 mg:
The other ingredients are: dibasic calcium phosphate (anhydrous), sodium croscarmellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132) and yellow iron oxide (E172).
90 mg:
The other ingredients are: dibasic calcium phosphate (anhydrous), sodium croscarmellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, hypromellose, titanium dioxide (E171) and triacetin.

What XETORIB looks like and contents of the pack
XETORIB 60 mg: green, oblong, film-coated tablets
XETORIB 90 mg: white, round, film-coated tablets
XETORIB 120 mg: green, round, film-coated tablets

60 mg, 90 mg:
XETORIB is available in packs of 10 or 20 film-coated tablets.
120 mg:
XETORIB is available in packs of 5 film-coated tablets.

Marketing Authorization Holder
I.B.N. Savio Srl
Via del Mare, 36 Pomezia (RM) Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira,
2710-089 Sintra,
Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy XETORIB